اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CYSTAGON از شرکت MYLAN
New Drug Application (NDA): 020392
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYSTAGON | CYSTEAMINE BITARTRATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription |
None |
Yes | No |
| CYSTAGON | CYSTEAMINE BITARTRATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/15/1994 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/06/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/2007 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020392s010ltr.pdf |
||
| 01/30/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20392slr007ltr.pdf |
|
| 04/06/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20392S5ltr.pdf |
|
| 03/05/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/12/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/28/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/06/2007 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020392s010lbl.pdf |
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